Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Copper Cu 64 PSMA I&T: Radiopharmaceutical PET imaging tracer injected intravenously for staging of prostate cancer.
Study summary
This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.
Eligibility
Primary outcome measure(s)
- Sensitivity — 4 Hours
Determine the presence of metastatic pelvic lymph nodes relative to histopathology reference standard. At least one positive pelvic lymph node on the PET scan and one positive lymph node as determined by histopathology on the same side of the pelvis (left or right) will be counted a true positive at the patient level. - Specificity — 4 Hours
Determine the absence of metastatic pelvic lymph nodes relative to histopathology reference standard. Negative pelvic lymph node on the PET scan and negative pelvic lymph nodes as determined by histopathology on the same side of the pelvis (Left or Right) will be counted a true negative at the patient level.
Trial sites (43)
| Facility | City | Region | Status |
|---|---|---|---|
| Urology Centers of Alabama | Homewood | Alabama | |
| Arkansas Urology | Little Rock | Arkansas | |
| Providence Medical Foundation | Fullerton | California | |
| Tower Urology | Los Angeles | California | |
| VA Greater Los Angeles Healthcare System | Los Angeles | California | |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | |
| University of California, Irvine | Orange | California | |
| San Francisco VA Medical Center | San Francisco | California | |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | |
| Providence Saint John's Health Center | Santa Monica | California | |
| Stanford Hospital & Clinics | Stanford | California | |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | |
| University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center | Miami | Florida | |
| CIRA Health | Miami | Florida | |
| Sarasota Memorial Health Care System | Sarasota | Florida | |
| Florida Urology Partners | Tampa | Florida | |
| Edward Hines Jr. VA Hospital | Hines | Illinois | |
| Urology of Indiana, LLC | Carmel | Indiana | |
| IU Health Neuroscience Center | Indianapolis | Indiana | |
| University of Iowa | Iowa City | Iowa | |
| The University of Kansas Hospital | Kansas City | Kansas | |
| United Theranostics | Glen Burnie | Maryland | |
| VA Boston Healthcare System | Boston | Massachusetts | |
| M Health Fairview University of Minnesota Medical Center | Minneapolis | Minnesota | |
| SSM Health Saint Louis University Hospital | St Louis | Missouri | |
| John Cochran VA Medical Center | St Louis | Missouri | |
| Great Plains Health, Diagnostic Imaging | North Platte | Nebraska | |
| XCancer | Omaha | Nebraska | |
| United Theranostics | Princeton | New Jersey | |
| Adaptive Research Inc. | Hawthorne | New York | |
| Columbia University Medical Center | New York | New York | |
| James J. Peters VA Medical Center | The Bronx | New York | |
| UNC Cancer Center | Chapel Hill | North Carolina | |
| Cleveland Clinic | Cleveland | Ohio | |
| Dayton Physicians Network / Greater Dayton Cancer Center | Kettering | Ohio | |
| VA Portland Health Care System | Portland | Oregon | |
| Hollings Cancer Center | Charleston | South Carolina | |
| Carolina Urologic Research Center, LLC | Myrtle Beach | South Carolina | |
| University of Tennessee Medical Center | Knoxville | Tennessee | |
| Excel Diagnostics and Nuclear Oncology Center | Houston | Texas |
+ 3 more sites — see the full list on the official registry below.
More Curium US LLC trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06235151 on ClinicalTrials.gov ↗ ← All trials in the USA